BD FACS¿ SAMPLE PREP ASSISTANT III

Additional Manufacturer Narrative

COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III LEAKAGE OF BIOHAZARD COMING FROM THE INSTRUMENT WAS DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "1. WAS THE LEAK LIQUID OR AIR? (IF LIQUID/BOTH, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.): LIQUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? (IF NOT CONTAINED, GOT TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.): NOT CONTAINED. 3. WAS THERE SPRAY OF LIQUID UNDER PRESSURE? (IF YES, DESCRIBE THE LIQUID THAT SPRAYED THEN GO TO QUESTION #7. IF NO, TYPE ¿NO¿ IN THE TEXT BOX THEN GO TO QUESTION #4). 4. WHAT WAS THE FLUID THAT LEAKED? (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD/UNKNOWN, GO TO QUESTION #5): NON BIOHAZARD. THE WASTE TOWER IS OVERFLOWING".

Additional Manufacturer Narrative

AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT WAS SENT IN ERROR. ALTHOUGH THE LEAK WAS FROM THE WASTE TOWER, IT WAS NON-BIOHAZARDOUS WASTE THAT WAS LEAKING, THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III LEAKAGE OF BIOHAZARD COMING FROM THE INSTRUMENT WAS DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "1. WAS THE LEAK LIQUID OR AIR? (IF LIQUID/BOTH, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.): LIQUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? (IF NOT CONTAINED, GOT TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.): NOT CONTAINED. 3. WAS THERE SPRAY OF LIQUID UNDER PRESSURE? (IF YES, DESCRIBE THE LIQUID THAT SPRAYED THEN GO TO QUESTION #7. IF NO, TYPE ¿NO¿ IN THE TEXT BOX THEN GO TO QUESTION #4): 4. WHAT WAS THE FLUID THAT LEAKED? (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD/UNKNOWN, GO TO QUESTION #5): NON BIOHAZARD. THE WASTE TOWER IS OVERFLOWING."

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY (B)(4). PN: 647205 SPAIII SN: (B)(6) DATE REPORTED: 07/27/2022. INVESTIGATION SUMMARY: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII AND SERIAL NUMBER: (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED: WASTE TOWER IS OVERFLOWING. MANUFACTURING DEFECT TREND: THERE ARE (B)(4) QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 27JUL2021 TO DATE 27JUL2022 (ROLLING 12 MONTHS). COMPLAINT TREND: THERE ARE (B)(4) COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 27JUL2021 TO DATE 27JUL2022 (ROLLING 12 MONTHS) . COMPLAINT DATA ATTACHED. INVESTIGATION RESULT / ANALYSIS: PER FSE¿S REPORT: REMOVED CLOG FROM THE WASTE LINE. NO FURTHER ISSUES. SAMPLE PREPARATION WAS NOT AFFECTED. THERE WAS NO DELAY IN PATIENT TREATMENT DUE TO ANY UNEXPECTED RESULTS. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# (B)(4). INSTALL DATE: (B)(6) 2018. DEFECTIVE PART NUMBER: 3343494 ¿ PROBES WITH CAPSULES (3). WORK ORDER NOTES: SUBJECT / REPORTED: WASTE TOWER IS OVERFLOWING, PROBLEM DESCRIPTION: WASH TOWER IS OVERFLOWING, CAUSE: CLOGGED WASTE LINE, WORK PERFORMED: REMOVED CLOG FROM WASTE LINE, SOLUTION: REMOVED CLOG FROM WASTE LINE. RETURNED SAMPLE EVALUATION: DID NOT REQUEST RETURN OF PROBE. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: (B)(6) AND PN647205 WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. RISK ANALYSIS: RISK MANAGEMENT FILE PART #100245RA, REVISION 03 WAS REVIEWED. HAZARD(S) IDENTIFIED? YES NO. HAZARD ID: 3.1.29 _. HAZARD: ENVIRONMENTAL BIOHAZARD. SEVERITY: 5. PROBABILITY: 1. RISK INDEX: 5. IMPLEMENTATION: BD FACS SAMPLE PREP USER¿S GUIDE__. RISK CONTROL:_AFAP_____. MITIGATION(S) SUFFICIENT YES NO. ROOT CAUSE: BASED ON THE INVESTIGATION RESULT AND THE FSE¿S REPORT THE ROOT CAUSE WAS CLOGGED WASTE LINE. CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE CALL REPORT THE COMPLAINT WAS CONFIRMED FOR WASH TOWER OVERFLOWING. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO ANY INCORRECT RESULTS. THERE WAS NO IMPACT TO THE PATIENT HEALTH OR SAFETY.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III LEAKAGE OF BIOHAZARD COMING FROM THE INSTRUMENT WAS DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "1. WAS THE LEAK LIQUID OR AIR? (IF LIQUID/BOTH, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.): LIQUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? (IF NOT CONTAINED, GOT TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.): NOT CONTAINED. 3. WAS THERE SPRAY OF LIQUID UNDER PRESSURE? (IF YES, DESCRIBE THE LIQUID THAT SPRAYED THEN GO TO QUESTION #7. IF NO, TYPE ¿NO¿ IN THE TEXT BOX THEN GO TO QUESTION #4):. 4. WHAT WAS THE FLUID THAT LEAKED? (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD/UNKNOWN, GO TO QUESTION #5): NON BIOHAZARD. THE WASTE TOWER IS OVERFLOWING."